drugset / Trial / NCT02486133
Dual Therapy With Boosted Darunavir + Dolutegravir
RandomizedParallel-groupOpen-labelTreatment
Summary
A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV) Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with RTV-boosted DRV in combination with 2 NRTIs.
Timeline
- Start
- 2015-07
- Primary completion
- 2018-05-31
- Completion
- 2018-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dolutegravir | Other / unclassified | 50 mg | — |
| Comparator | Raltegravir | Other / unclassified | — | — |
| Comparator | Tenofovir | Small molecule | — | — |
| Comparator | tenofovir alafenamide | Small molecule | — | — |
| Background | Darunavir-ritonavir | Unknown | 800 mg | — |
| Background | Ritonavir | Other / unclassified | — | — |